Stool Softener
- Product NDC
- 57896-401
- 11-digit product format
- 578960401
- Labeler code
- 57896
- Product ID
- 57896-401_08173bad-d29e-d916-e063-6394a90a609f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Geri-Care Pharmaceutical Corp
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2000-01-01
- Substance
- DOCUSATE SODIUM
- Active strength
- 100 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 57896-401-10 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 57896-401-01 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 57896-401-25 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 57896-401-03 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 57896-401-10 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 57896-401-01 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 57896-401-25 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 57896-401-03 | 110d247fa046… | a55b01930146… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Stool Softener
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1115005 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 644d81ec-d38f-4172-a087-727b94e2fefe | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 57896-401-01 | 2020-09-29 | gc 401 |
| 57896-401-03 | 2020-09-29 | gc 401 |
| 57896-401-10 | 2020-09-29 | gc 401 |
| 57896-401-25 | 2020-09-29 | gc 401 |
| 57896-401-01 | 2019-11-27 | gc 401 |
| 57896-401-03 | 2019-11-27 | gc 401 |
| 57896-401-10 | 2019-11-27 | gc 401 |
| 57896-401-25 | 2019-11-27 | gc 401 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57896-401-01 | Stool Softener | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | 4 | |
| 57896-401-03 | Stool Softener | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | 4 | |
| 57896-401-10 | Stool Softener | 1000 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 1000 | 4 | |
| 57896-401-20 | Stool Softener | 200 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 200 | 4 | |
| 57896-401-25 | Stool Softener | 250 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 250 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-401-01 | EA - Each | 57896-401 | da8e6844-b6ae-4244-8bfc-f7ad99d8eaf8 | 1 | 2013-06-04 |
| 57896-401-03 | EA - Each | 57896-401 | 6762957d-d7f6-4213-a664-2c7f42fc9f36 | 1 | 2013-06-04 |
| 57896-401-10 | EA - Each | 57896-401 | 7ae1d03c-6162-4398-b8d2-1946db28e941 | 1 | 2013-06-04 |
| 57896-401-20 | EA - Each | 57896-401 | 8f701acd-94d7-43d2-9072-f8fbf72510af | 1 | 2021-02-05 |
| 57896-401-25 | EA - Each | 57896-401 | 5c82cab7-f225-43ff-b3f5-38f5ffd4b01a | 1 | 2018-11-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Laxative Docusate Sodium with Senna | DOCUSATE SODIUM AND SENNOSIDES | TOPCO ASSOCIATES LLC | cf9075d8-e20e-419a-b996-9b12f49f05f2 | 2025-01-01 | Warnings | M007 |
| Vegetable Laxative and Stool Softner | DOCUSATE SODIUM AND SENNOSIDES | TOPCO ASSOCIATES LLC | e84d693d-0041-4c11-8f6a-b5c332f79af9 | 2025-01-01 | Warnings | M007 |
| Acetaminophen | EXTRA STRENGTH PAIN RELIEF | NuCare Pharmaceuticals,Inc. | a32f346e-71d0-cc11-e053-2a95a90ae88c | 2024-12-31 | Warnings | M007 |
| Laxacin | DOCUSATE SODIUM AND SENNOSIDES | Advanced Rx Pharmacy of Tennessee, LLC | fe7d4d75-0f8a-1e7d-e053-6394a90afb4d | 2024-12-31 | Warnings | M007 |
| NATUREPLEX Enema | (SALINE) | Natureplex, LLC | 0bd6d0a8-33e5-40be-a6c6-33fea92b11dd | 2024-12-31 | Warnings | M007 |
| Magnesium Citrate | CVS MAGNESIUM CITRATE ORAL SOLUTION - LEMON | CVS Pharmacy, Inc. | fb7f9b67-ff0e-3af4-e053-6294a90ac539 | 2024-12-30 | Warnings | M007 |
| Magnesium Citrate | CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | CVS Pharmacy, Inc. | fb808dc5-bf80-836c-e053-6294a90a80aa | 2024-12-30 | Warnings | M007 |
| Magnesium Citrate | CVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | CVS Pharmacy, Inc. | fb80ffce-a7b6-7f19-e053-6294a90a5c6b | 2024-12-30 | Warnings | M007 |
| Foster and Thrive Castor Oil | CASTOR OIL | Strategic Sourcing Services, LLC | 004d1dc2-47c1-84d1-e063-6394a90a2471 | 2024-12-30 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | A-S Medication Solutions | 946abcdb-96bd-43e6-992a-bb97679c00f0 | 2024-12-30 | Warnings | M007 |
| HEB Maximum strength Laxative pills | SENNOSIDES | H E B | 86e5dff5-91e6-47a5-8f3c-b1e86adfc1f4 | 2024-12-26 | Warnings | M007 |
| Equaline Regular Strength Chocolated Stimulant Laxative | SENNOSIDES | United Natural Foods, Inc. dba UNFI | e9200d63-a0d1-4f68-bb5e-7507c46cf800 | 2024-12-26 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | WALGREEN COMPANY | effad954-b70d-d8e6-e053-2a95a90acaf7 | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | WALGREEN COMPANY | effad365-d76e-71af-e053-2995a90aa020 | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | WALGREEN COMPANY | effaeff6-c48b-1558-e053-2995a90ab52f | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | STRATEGIC SOURCING SERVICES | f9e1291a-f64d-2431-e053-6394a90a35f1 | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | AMERISOURCE BERGEN | f384094e-c4d2-3882-e053-2995a90a7794 | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | AMERISOURCE BERGEN | f3847b0f-802d-73d7-e053-2a95a90a5bbe | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | STRATEGIC SOURCING SERVICES | f9e1291a-f650-2431-e053-6394a90a35f1 | 2024-12-23 | Warnings | M007 |
| Leader Regular Strength Chocolate Laxative sennosides | SENNOSIDES | CARDINAL HEALTH | 1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e | 2024-12-23 | Warnings | M007 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57896-401-01 | 57896040101 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-01) | 2020-09-01 | 0000-00-00 | No | No | Current |
| 57896-401-03 | 57896040103 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-03) | 2020-09-01 | 0000-00-00 | No | No | Current |
| 57896-401-10 | 57896040110 | 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-10) | 2020-09-01 | 0000-00-00 | No | No | Current |
| 57896-401-20 | 57896040120 | 200 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-20) | 2020-09-01 | 0000-00-00 | No | No | Current |
| 57896-401-25 | 57896040125 | 250 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-25) | 2020-09-20 | 0000-00-00 | No | No | Current |